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Abstract:

A protective coating solution, liquid, gel, or film and a method of using
such a material to provide a sterile covering for fingers, hands, arms or
other selected skin surface for use as a glove substitute.

Claims:

1. A method of coating a predetermined skin surface with a protective
coating including the steps of: providing a coating solution; selecting a
predetermined skin surface for application of said coating solution;
applying said coating solution to said skin surface; and drying said
coating solution.

2. The method of claim 1 wherein said predetermined skin surface
comprises at least one hand.

4. The method of claim 1 wherein said step of applying said solution
comprises dipping said predetermined surface into said solution.

5. The method of claim 1 wherein said step of applying said solution
comprises spraying said predetermined surface with said solution.

6. The method of claim 1 wherein said step of applying said solution
comprises the steps of: forming a film of said solution; and applying
said film to said predetermined surface.

7. The method of claim 1 wherein said step of applying said solution
comprises the steps of: providing a hoop device; inserting said hoop
device into a container of said solution; collecting a film of said
solution on said hoop device; and applying said film to said
predetermined surface.

8. The method of claim 1 wherein said solution is a polymer.

9. The method of claim 1 wherein said solution is a silicone.

10. The mod of claim 8 wherein said solution further includes an
antiseptic.

11. The method of claim 9 wherein said solution further includes an
antiseptic.

12. The method of claim 1 wherein said solution is a collodion.

13. The method of claim 12 wherein said solution further includes an
antiseptic.

Description:

[0002] The present invention relates to a sterile covering or barrier
protective liquid, gel, material or film and, more particularly to a
method of using such a material to create a sterile covering for fingers,
hands, arms or other selected skin surface to act as glove substitute.

[0003] During surgery and other medical procedures sterility is essential
to prevent contamination and the spread of diseases, bacteria and
viruses. Likewise, it is also essential that hand coverings do not limit
the surgeon's or medical personnel's feel and touch, e.g. tactile
sensation, when performing a medical procedure or examination. In
addition, areas like the food industry, salon services, dentistry and a
wide variety of other manufacturing and specialty services require
protection for themselves and their patients or clients.

[0004] Most commonly, surgical gloves, e.g. latex gloves and non latex
polymers, are standard and used during surgery and other procedures.
However, the use of surgical gloves may be a cumbersome process when
putting on and removing the gloves, creates a great deal of solid waste
and may be overkill for certain smaller procedures. They also create a
tactile barrier to the sensitivity or the surgeon or person wearing the
gloves. While there have been improvements in the strength and thinness
of these gloves, they nonetheless tend to be thicker than desired, adding
to diminished tactile feeling of the surgeon or medical personnel. There
is also increasing medical evidence to show that most patient infections
originate from the patient's own skin verses the surgeon's skin.
Therefore protection is needed for both the operator and the patient or
client.

[0005] Artificial skins have been developed that are used to treat sores
and wounds on a patient. Such artificial skins may be sprayed onto the
skin or applied topically to particular areas of the skin. However, such
artificial skins are not well adapted for surgical uses, as they do not
necessarily hold up and are not durable enough to a function in a
surgical environment. Further, they do not provide for an adequate
barrier of protection, and in addition may not prevent bacteria from
growing on the surface as a biofilm.

SUMMARY OF THE INVENTION

[0006] The present invention provides a surgical finger, hand, or arm
barrier covering and a method and system of applying the covering. The
hand covering provides a durable barrier between medical personnel and a
patient during a surgical procedure or examination and also with other
nonmedical uses as described above. The hand covering is resistant to
dissolution when in contact with bodily fluids or water so that it will
retain its protective barrier during the particular medical procedures or
examinations, would bind any residual bacteria into the follicles or
skin, and create a sterile surface over the fingers or hands
circumferentially creating a sterile barrier. In addition, and as a
completely different application, the material may also be used as a skin
prep application or sealant after the skin prep and applied directly over
the skin were an incision is to be made or to cover areas such as the
nipple to prevent any bacteria coming from out of the ducts and onto the
skin surface or into the wound.

[0007] The present further invention contemplates a method of providing
the fingers, hands, or arms with a covering for use during a surgical
procedure, and a method of providing a finger covering or a sterile
covering for the fingertips only. The process includes dipping the user
or medical personnel's fingers or hands in a solution, or suspension of
material, removing the hands, and allowing the solution to dry, thereby
forming the surgical hand covering. Once the medical procedure is
finished, the fingers or hands may be washed in a solution or solvent
that will remove the surgical hand covering, if needed. As an
alternative, the solution or suspension may be applied to the hands and
rubbed in evenly to provide uniform coverage.

[0008] The present invention further contemplates a finger dip apparatus
for retention of the solution or suspension, and into which the fingers
may be dipped for application. A larger apparatus may also be used to
accommodate the entire hand, entire arm, or other larger body area for
uniform application of the suspension.

[0009] Alternatively, a sprayer system may be utilized to spray and or
dispense the material. After application of the suspension by the
sprayer, the covering would be allowed to air dry or may be placed into a
air blower or dryer to be dried more quickly.

[0010] In another embodiment, the coating is applied as an extremely thin
film to the fingers, hands or arms and peeled off for removal, or removed
with a solvent.

[0011] The specific material to be used as a coating may be a single agent
such as a silicone or other plastic polymer or a may be combination of
materials including antiseptics such as those marketed under the names
CHLORAPREP®, HIBICLENS®, BETADINE®. Other alcohols and
antibiotics that may further suppress bacteria may be used in combination
with other materials such as flexible Collodion, ether free Collodion,
cyanoacrylates such as those used in SUPER GLUE®, and DERMABOND®
materials. Any of these combinations may also be applied as a thin film
or plastic polymer.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] FIG. 1A depicts the process of applying prior art gloves for use in
a medical procedure.

[0013] FIG. 1B depicts the gloves of FIG. 1A being removed after use in
medical procedure.

[0014]FIG. 2 demonstrates a first step for applying a surgical finger or
hand coating according to the present invention.

[0015] FIG. 3 provides a subsequent step for applying a surgical fingers
or hand coating according to the present invention, with the hands being
submersed into a solution containing the surgical hand covering material.

[0016]FIG. 4 provides a further step for applying a surgical finger or
hand coating according to the present invention, with the hand being
removed from the solution and allowed to dry.

[0017] FIG. 5 provides an alternate step for the present solution wherein
the hands are rubbed together after being removed from the hand covering
solution.

[0018] FIG. 6 depicts a user, such as a surgeon, performing a medical
procedure while using the surgical hand coating of the present invention.

[0020] FIG. 8 demonstrates a user, such as a surgeon, removing any
remaining surgical hand coating by washing the hands in a rinse solution.

[0021] FIG. 9 depicts an alternate first step in the process of the
present invention, wherein only the fingers are immersed in the solution
containing the surgical hand covering material.

[0022] FIG. 10 depicts the fingers of FIG. 9 being removed from the
solution and allowed to dry.

[0023] FIG. 11 demonstrates the use of a syringe after application of the
hand solution as shown in FIG. 10.

[0024] FIG. 12 depicts an alternative first step for applying the material
as a spray that is sterilely sprayed on to the user's selected skin
surface and allowed to dry or rubbed into the hands or arms.

[0025] FIG. 13 depicts an alternative first step for applying the
material, and showing a hoop device inserted into a vessel containing the
material.

[0026] FIG. 14 depicts a subsequent step for the method depicted in FIG.
13, in which the hoop device retains a film of material and the user
inserts a selected skin surface, seen as a hand in this view, into the
film.

[0027] FIG. 15 depicts another alternative first step for applying the
material, and showing an applicator device transferring the material to a
selected skin surface.

[0028] FIG. 16 depicts another alternative first step for applying the
material, and showing a thin film of the material draped over a selected
skin surface.

DESCRIPTION OF THE PREFERRED EMBODIMENT

[0029] Although the disclosure hereof is detailed and exact to enable
those skilled in the art to practice the invention, the physical
embodiments herein disclosed merely exemplify the invention which may be
embodied in other specific structures. While the preferred embodiment has
been described, the details may be changed without departing from the
invention which is defined by the claims.

[0030] FIGS. 1A and 1B demonstrate prior art gloves 10 for use in surgical
procedures. In FIG. 1A, the gloves 10 are being applied prior to a
surgical or medical procedure. The surgeon or other medical personnel
will pull the gloves 10 over their hands 11 and adjust them so that they
fit properly on the user's hands 11. The gloves 10 are normally made from
a thin silicone, latex or rubber material, e.g. latex, that allow the
gloves 10 to be flexible enough so that the user can adjust them for
proper fit. Because the gloves 10 are mass produced, the gloves 10 may
not adequately fit the user's hands, either being too tight and not
properly conforming to the specific user's hands, or they may be too
loose, which can result in the gloves 10 being a hindrance during a
surgical procedure. If the gloves 10 are too tight, the gloves 10 may
also rip when being put on, thereby causing the person to have to remove
the gloves, throw them away, and put on a new set of gloves. In addition
the glove thickness decreases the tactile sensation or the wearer and
also creates and adds to the great medical waste burden.

[0031] FIG. 1B demonstrates the gloves 10 being removed from the user's
hands 11. Removal may be a tedious process, particularly if the gloves 10
tightly fit the user's hands. This is also true because the material of
the gloves 10 must also be sufficiently strong to resist tearing and rips
that may occur during use.

[0032] As previously noted, the materials used for these gloves 10 are
rubber materials such as latex, or other materials with similar
properties. Though the gloves 10 are designed to be thin, they must be
sufficiently strong, e.g. thick, so that they will not fail during use,
often diminishing or lessening the tactile feel of the user.

[0033] The present invention provides an alternative to gloves 10. The
present invention comprises a surgical hand covering that may be applied
to the user's fingers in particular and or the hands in general, or may
be used to cover any other skin surface. The hand covering will be used
in lieu of gloves 10 being put on the user's hands.

[0034]FIG. 2 shows the user's hands 11 prior being covered with the
surgical hand covering of the present invention. The user's hands 11 will
be washed and sterilized, as is typically done before surgical or medical
procedures. A container 13 holding a coating solution 12 is made
available to receive the user's hands 11. The user's hands will be
sufficiently dry such that when they are put into the coating solution
12, the coating solution 12 will sufficiently adhere to the selected skin
surface, such as the hands 11 shown in these views.

[0035] As is shown in FIG. 3, the user dips a selected skin surface, such
as hands 11, into the container 13 so that the hands 11 are covered by
the solution 12. The user will keep them within the solution 12 for a
sufficient period of time necessary to coat the hands 11. The immersion
time may be determined by the user. For example, the user may immerse
just finger tips into the solution 12 for a quick, simple procedure, e.g.
an office check-up, or may immerse the entire hand or arm for use in a
more intricate or involved procedure, as for example, a surgical
operation. As such, the present invention provides a hand covering that
may be tailored particularly to the needs of a specific user and a
specific procedure.

[0036] With attention now to FIG. 4, it may be seen that once the hands 11
are sufficiently coated by the solution 12, the user will remove the
hands 11 from the solution 12. Any excess coating solution 12 may be
removed from the user's hands, if desired, by allowing the excess
solution 12 to drip off. The hands 11 are preferably allowed to dry for a
predetermined time prior to the performance of the medical or surgical
procedure, whereby the surgical hand coating 14 of the present invention
is formed. The coating solution 12 is preferably a quick drying solution
to insure the hand coating 14 provides the necessary barrier against
contamination prior to performing the particular procedure or operation.
The step of dipping the hands into the solution 12 may be repeated if
additional thickness is required.

[0037] FIG. 5 provides a further step of the method of the present
invention. After the user has removed his hands as shown in FIG. 4, the
user may rub his hands together so that the coating solution 12 will be
evenly distributed and worked into all portions of the skin, thereby
further increasing the hygienic barrier formed by the coating solution
12.

[0038] As shown in FIG. 6, the user is able to perform the medical
procedure, without the need for gloves 10. The surgical hand coating 14
provides a sterile barrier that sufficiently prevents the transmission of
unwanted materials, e.g. bacteria, in the same manner as for the prior
art gloves. Further, the surgical hand coating 14 is thinner than the
gloves 10 and directly follows the contours of the individual user's
hands, which increases the tactile feel of the user. The result is that
the user has better and more precise feel when carrying out a procedure.

[0039] Once the surgical procedure is completed, the surgical hand coating
14 may be peeled away from the user's hands, as is shown in FIG. 7. Any
remaining surgical hand coating 14 may be further washed away in a
solvent 16 particular to the composition of the coating solution 12, as
is shown in FIG. 8. Alternatively, the coating solution 12 may be simply
washed away without first peeling away the coating 14.

[0040] The surgical hand coating 14 of the present invention and the
methods of forming the surgical hand coating 14 also allow for hand
coatings 14 to be directed towards particular body parts, e.g. the user's
fingers. As shown in FIG. 9, the user may dip only the fingers into the
coating solution 12. The fingers are removed and allowed to dry, as shown
in FIG. 10, in the similar fashion as described previously with respect
to the coating for the entire hand.

[0041] The ability to isolate the surgical hand coating 14 to a particular
skin surface reduces waste and costs associated with prior art hand
coverings 10. For example, as shown in FIG. 11, the user may apply the
coating only to the fingers, which thereby provides a sufficient barrier
for certain routine procedures, such as delivering or injecting a
medication with a syringe 18. Since it is not necessary to sterilize the
entire hand for such a procedure, use of the present coating 14 on the
fingers only, relieves the user of the unnecessary time and effort
required to apply full gloves 10 on the hand. Thus, the procedure is made
more efficient than use of the prior art gloves 10, while also being more
cost effective.

[0042] In addition to providing a better fit than prior art gloves 10 and
other known hand coverings, the present invention also allows the user to
be more responsive to potential problems during a medical procedure. For
example, because tactility is improved with the present invention, the
user is more able to realize if an instrument pierces through the
surgical coating 14. This minimizes the possibility that contamination is
transmitted through open wounds. In the same fashion, the surgical
coating solution 12 may include skin color changing agents that react
when the surgical coating 14 is pierced, thereby warning the user if the
surgical coating 14 is compromised. For example, the surgical coating 14
may change color when pierced by a surgical instrument. Surgical gloves
sold under the BIOGEL PI INDICATOR® System name may be seen as an
example of such a feature.

[0043] As seen in FIGS. 12-16, alternative methods of applying the coating
solution 12 to a selected skin surface may be envisioned. For example,
and as seen in FIG. 12, the solution 12 may be applied by spraying. FIGS.
13 and 14, illustrate the solution 12 applied by way of a hoop device 20
inserted into a container 13 holding the solution 12. As further seen in
FIG. 14, the hoop device 20 forms and retains a film 22 of solution 12
while the user inserts a selected skin surface, seen as a hand 11 in this
view, into the film 22.

[0044] The novel solution 12 may also be applied to the skin as a surgical
prep solution that will also bind any bacteria to create a biofilm into
the skin thereby decreasing contamination. The view of FIG. 15
illustrates a first step for applying the solution 12 in this manner, and
shows an applicator device 24 transferring the solution 12 to a selected
skin surface, seen as a hand 11.

[0045] Yet another method for applying the solution 12 to a selected skin
portion may be seen in FIG. 16. In this view, the solution 12 is
illustrated as a film 22 that may be draped over the hand 11, or other
skin surface.

[0046] The present invention may be formulated from any material that will
provide the necessary protective coating while providing an improved
tactile feeling as compared to prior art gloves. For example the material
may be a silicone polymer or a combination of silicone, and other
materials such as an antiseptic, antimicrobial, antibiotic, or other skin
sealants such as collodion or cyanoacrylates. Other examples of
acceptable coating materials include polymers, such as a polyester
material, a PEG material, a polyvinyl material, a nylon material,
synthetic rubber, a polypropylene material, or other material that is
capable of forming a surgical hand coating 14 and that will form the
necessary artificial barrier according to the present invention. The
material will allow for a surgical hand coating 14 that is flexible when
applied to the user's hands so as to not crack, break, or rupture during
a surgical procedure, examination or other manual uses. The material will
also be thin enough when dried so that the user will have increased feel
when compared to prior art gloves. As mentioned, the specific material to
be used as a coating may be a single agent such as a silicone or other
plastic polymer or a may be combination of materials including
antiseptics such as those marketed under the names CHLORAPREP®,
HIBICLENS®, BETADINE®. Other alcohols and antibiotics that may
further suppress bacteria may be used in combination with other materials
such as flexible Collodion, ether free Collodion, cyanoacrylates such as
those used in SUPER GLUE®, and DERMABOND® materials. Any of these
combinations may also be applied as a thin film or plastic polymer.

[0047] The prior art does not provide a method wherein a surgical coating
is provided that will provide a barrier against bacteria and other
contaminants, without the requirement of an external glove or other
materials to be used in concert with the surgical hand coating 14. Prior
art gloves 10 are pre fit and preformed versus the present invention of
an application of a solution or suspension that is allowed to bind to the
skin and provide a custom fit physical barrier to the transgressions of
bacterial or contamination and will protect both the patient or the
client as well as the physician, surgeon or user.

[0048] The foregoing is considered as illustrative only of the principles
of the invention. Furthermore, since numerous modifications and changes
will readily occur to those skilled in the art, it is not desired to
limit the invention to the exact construction and operation shown and
described. While the preferred embodiment has been described, the details
may be changed without departing from the invention.